Systems and methods for measuring volume of potential sleeve in a sleeve gastrectomy

ABSTRACT

One or more medical devices may be provided that may be used, for example, in bariatric surgery including a vertical sleeve gastrectomy. Occlusion devices can be integrated with a catheter or tube to occlude one or more proximal or distal landmarks of a stomach and a stapling guide may be used to occlude a lateral boundary of the stomach to define a cavity. A volume of the potential resultant sleeve may be determined by inserting fluid or gas into the catheter or tube, measuring pressure, and calculating the volume of the cavity.

REFERENCE TO RELATED APPLICATION

This application is a continuation application of U.S. non-provisionalapplication Ser. No. 15/267,414, filed Sep. 16, 2016, which claimspriority to U.S. Provisional Patent Application No. 62/219,564, filedSep. 16, 2015, which are hereby incorporated by reference in theirentirety.

BACKGROUND

Obesity is a disease that affects a significant portion of the world'spopulation and leads to multiple chronic medical conditions andpremature death from cardiovascular events and cancer. In particular,the United States has a current, and worsening obesity epidemic. TheU.S. Centers for Disease Control and Prevention (CDC) reports that over33% of the U.S. population is obese, with a Body Mass Index (BMI) ofover 30, and another 35-40% of the US population is overweight, with aBMI of 25-30. The CDC reports that the percent of the US populationbeing either overweight or obese by 2018 will be 75%. The CDC alsoreports that obesity directly costs the U.S. economy $147 billioncurrently, and projects that the costs will approach $315 billion by2020.

Further, obesity has environmental, genetic and behavioral origins butis intractable to most medical and behavioral interventions. To helpreduce obesity and/or facilitate weight loss, bariatric surgery may bean option for some patients that may be overweight. Typically, bariatricsurgery may be an effective long-term treatment option for patients witha BMI greater than 35. Despite the 20 million patients who are eligiblefor weight loss surgery in the U.S., the number of procedures per yearhas plateaued at about 200 thousand, eliminating any public healtheffect of surgery.

In recent years, a popular form of bariatric surgery may include alaparoscopic vertical sleeve gastrectomy (e.g., which may removeapproximately 80% of the stomach). Laparoscopic vertical sleevegastrectomy may be a procedure that may be safer and more effective forpatients eligible for weight loss surgery. In fact, it has been acceptedas the surgery that should be offered to most morbidly obese patientsover, for example, laparoscopic adjustable gastric banding andlaparoscopic Roux-en-Y gastric bypass. As such, the surgery has beenadopted by bariatric surgeons and is now the most commonly performedweight loss surgery.

Vertical sleeve gastrectomy is typically performed using standardlaparoscopic equipment. The greater curvature of the stomach ismobilized using vessel-sealing devices, sealing the gastric branches ofthe gastroepiploic vessels and the short gastric vessels. The posterioradhesions of the stomach are also divided so the stomach is fullymobilized while the blood supply to the lesser curvature remains intact.

Following mobilization of the stomach a calibration tube is typicallyintroduced into the stomach through the mouth. Resection is accomplishedby applying a series of staples from a laparoscopic linear surgicalstapler, for example, along the calibration tube in a staple line. Thestaple line may be important in sleeve gastrectomy as the amount ofweight lost and complications or consequences may be a direct result ofthe quality of the resultant sleeve gastrectomy pouch formed from thestaple line (e.g., the portion of the stomach not rescinded by thestaple line). The complications or consequences may includegastroesophageal reflux disorder (GERD), weight loss failure or weightregain, food intolerance, staple line bleed, leak, and/or the like.

To perform the sleeve gastrectomy and produce sleeve gastrectomy pouch(e.g., from the staple line), a sleeve gastrectomy stapling guide and acatheter or tube may be used. Although the combination of the staplingguide and catheter or tube may help produce a better staple line, asurgeon may still need to estimate or envision an adequate distance toform the sleeve gastrectomy pouch with a suitable volume, shape, and/orsize. To help improve the volume, size and/or shape of the sleevegastrectomy pouch, the surgeon may want to measure volume of the sleevegastrectomy pouch prior to stapling. Unfortunately, currently, thevolume may be measured in follow ups after the sleeve gastrectomy mayhave been performed to diagnose problems that may have occurred and/ordetermine why the sleeve gastrectomy may not have been successful.Further, other surgical weight loss procedures such as vertical bandedgastroplasty that may provide techniques and/or devices to measurevolume of a pouch prior to placing a band at the area of the stomach thesurgeon wishes to remove as part of the pouch may not be suitable foruse in a sleeve gastrectomy. For example, those current techniques maynot provide a stapling guide that may be long enough to occlude thelength necessary to produce the staple line in a sleeve gastrectomy andalso may not provide devices and/or techniques to occlude the esophagusand the pylorus to pressure the sleeve gastrectomy pouch necessary tomeasure its volume.

SUMMARY

In an example herein, one or more medical devices may be provided thatmay be used, for example, in bariatric surgery including a verticalsleeve gastrectomy. The one or more medical devices may include alaparoscopic sleeve gastrectomy stapling guide in conjunction with acatheter or tube in accordance with one or more examples. According toan example, occlusion devices may be integrated with the catheter ortube or separate therefrom to occlude one or more proximal or distallandmarks of a stomach and the stapling guide may be used to occlude alateral boundary of the stomach. The area defined within the occludedportions and lateral boundary may be a potential resultant sleeve of thesleeve gastrectomy. A volume of the potential resultant sleeve may bedetermined by inserting fluid or gas into the catheter or tube,measuring pressure, and/or calculating the volume therefrom. In anexample, the volume of the sleeve may indicate whether a surgeon mayneed to make the potential resultant sleeve larger or smaller (e.g., bymoving the stapling guide or stapler) prior to stapling.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a front view of an example volume of a portion of astomach that may be measured in a banded gastroplasty in one or moreexamples.

FIG. 2 depicts a front view of an example volume of a potentialresultant sleeve that may be measured in a sleeve gastrectomy in one ormore examples.

FIG. 3 depicts a front view of a stomach shown with an inserted firstmedical device having a first occlusion portion has been insertedaccording to one embodiment.

FIG. 4 depicts a front view of a stomach with the inserted first medicaldevice shown in FIG. 3 in cooperation with a second occlusion deviceaccording to one embodiment.

FIG. 5 depicts a front view of a stomach shown with a sleeve volumemeasurement system having a compliant balloon associated with oneembodiment.

FIG. 6 depicts a front view of a stomach with the compliant balloon ofFIG. 5 shown with an associated sheath according to one embodiment.

FIG. 7 depicts a front view of a stomach with the compliant balloon ofFIG. 5 shown inflated.

FIG. 8 depicts a front view of the compliant balloon shown in FIG. 5shown in cooperation with the sheath shown in FIG. 6 according to oneembodiment.

FIG. 9 depicts a front view of a stomach shown with a compliant balloonin cooperation with a second wider balloon according to one embodiment.

FIG. 10 depicts a front view of the compliant balloon and the secondwider balloon shown in FIG. 9 in combination with a cylindrical balloonaccording to one embodiment.

FIG. 11 depicts a front view of the compliant balloon and the secondwider balloon shown in FIG. 9, the cylindrical balloon shown in FIG. 10,and a second cylindrical balloon according to one embodiment.

FIG. 12 depicts a front perspective view of a medical device having afirst occlusion portion and a second occlusion portion according to oneembodiment.

FIG. 13 depicts a front view of a stomach shown with the medical deviceof FIG. 12 according to one embodiment.

FIG. 14 depicts a front view of a stomach shown with a medical devicehaving a plurality of balloons according to one embodiment.

FIG. 15 depicts a front view of a stomach shown with a medical devicehaving a first region with a constant diameter and a second region witha diameter great then the diameter of the first region.

FIG. 16 depicts a partial perspective view of a region of a medicaldevice having a constant diameter according to one embodiment.

FIG. 17 depicts a partial perspective view of a medical device having afirst region with a first diameter and a second region with a seconddiameter, where the second diameter is great than the first diameter,according to one embodiment.

FIG. 18 depicts a front view of a medical device having a laterallyexpandable region according to one embodiment.

DETAILED DESCRIPTION

As described herein, systems and/or methods may be provided forperforming a sleeve gastrectomy. For example, a medical device may beprovided that may include a first medical device and a second medicaldevice. The first medical device may be positioned in an interior of thestomach. The first medical device may be a catheter or medical tube. Thefirst medical device may be positioned, for example, by inserting thefirst medical device into a mouth of a patient to access the interior ofthe stomach. In an example, the first medical device may include one ormore portions that may occlude landmarks of a stomach such as a pylorusand/or landmarks that may provide access to the stomach such as anesophagus. In an additional or alternative example, one or moreadditional medical devices that may not be integrated into the firstmedical device may be used in conjunction with the first medical deviceto occlude such landmarks. These additional devices may be exterior tothe stomach according to one example. According to one or more examples,the first medical device may allow or enable fluid to pass through itinto the stomach.

Further, in one example, the second medical device such as a clamp orstapler may be positioned on an exterior of the stomach such that thesecond medical device may be configured to demonstrate or create a pathsuch as a resection line or staple line along the stomach at which thesleeve gastrectomy may be performed. In one example, the second medicaldevice may be positioned on the exterior of the stomach relative to thefirst medical device (e.g., adjacent to, near, in proximity to, and/orthe like). In such an example, the first medical device may be used as areference to position the second medical device. The second medicaldevice may slide or move along the exterior of the stomach prior tostapling based on a sleeve volume that may be measured for a resultantsleeve.

As described herein, in one or more examples, the first medical devicein conjunction or combination with the second medical device and/or theone or more additional devices may be used to measure a volume of apotential resultant sleeve that may be formed thereby. FIG. 2illustrates an example volume of a potential resultant sleeve that maybe measured. As shown in FIG. 2, a volume of area B may be measured inone or more examples herein for a potential resultant sleeve in a sleevegastrectomy. The area B may be larger for a resultant sleeve in a sleevegastrectomy than an area A shown in FIG. 1 that may be provided in abanded gastroplasty and in which a volume may be measured. Further, asdescribed herein, a guide 2 that may be used in the banded gastroplastymay not be long enough (e.g., as compared to a second medical device 20)to occlude the length of the stomach to produce the staple line in asleeve gastrectomy and also may not provide devices and/or techniques(e.g., first and second occlusion devices) to occlude the first landmarkand the second landmark (e.g., the pylorus and esophagus at the GEJ orGE junction) to pressurize the potential resultant sleeve in a sleevegastrectomy at a level necessary to measure its volume as shown in FIGS.1 and 2.

In an example (e.g., upon reaching a suitable volume or desired volume),the sleeve gastrectomy (e.g., resection of part of the stomach) may beperformed along the path produced by the second medical device. Forexample, the surgeon may fully engage the second medical device and mayresect the stomach along the path to produce the resected resultantsleeve or permanent resultant upon reaching a suitable volume that mayproduce a resected or permanent resultant sleeve of the stomach. Forexample, a resection or staple line may be created (e.g., using asurgical stapler) along the path (e.g., staple line or resection line)thereby producing the resected or permanent resultant sleeve. In one ormore examples herein, the resultant sleeve of the stomach that may becreated by the path (e.g., the resection or staple line) may include adiameter of approximately 1 to 3 cm near the first landmark (e.g., theIA), approximately 2 to 6 cm near a second landmark (e.g., a pylorus) ofthe stomach, and approximately 0 to 2 cm near a third landmark (e.g., agastroesophageal junction (GEJ) or GE junction) of the stomach.

FIGS. 3-4 depict an example method or procedure and devices associatedtherewith that may be used to measure sleeve volume in one or moreexamples. As shown, a first medical device 10 may be inserted into astomach 40 through a mouth and positioned along a lesser curve (e.g.,the IA) of the stomach 40. The first medical device 10 may be a catheteror an elongated tube such as an orogastric tube that may be hollow orpartially hollow in examples. Further, in examples, the first medicaldevice 10 may include a plurality of catheters or elongated tubes thatmay be housed within each other (not shown). The first medical device 10may include one or more ports (not shown) at a proximal end thereof andone or more apertures or openings 12 at a distal end thereof. The portsmay be on the exterior of the stomach 40 and may receive fluid or gasthat may be passed through the first medical device 10 until it reachesthe apertures or holes 12. The fluid or gas may pass through theapertures and holes 12 into the interior of the stomach 40. As describedherein, the fluid or gas may be received and pass through the firstmedical device 10 into the stomach 40 such that a pressure may bemeasured and a volume calculated for a potential resultant sleeve.

In an example, the first medical device 10 may include a first occlusiondevice 14. In an example, the first occlusion device 14 may bepositioned past a landmark 40 a such as a pylorus of the stomach 40 suchthat when positioned past the landmark 40 a the first occlusion portion40 may occlude fluid or gas from passing or flowing beyond the landmark40 a in direction A. As shown, the first occlusion device 14 may be aballoon on the distal end of the first medical device 10 that may beinflated to occlude the landmark 40 a. As such, in an example, the firstocclusion device 14 may be integrated into the first medical device 10.

According to an additional or alternative example, the first occlusiondevice 14 may include another medical device such as clamp, penrose,band, and/or the like that may be used to occlude the landmark 40 a. Forexample, the first occlusion portion 14 may be a separate medical device(e.g., from the first medical device 10) that may be positioned at thelandmark 40 a (e.g., on an exterior of the stomach 40 or wrappedtherearound) to occlude fluid or gas from passing beyond the landmark 40a in direction A.

In an example, a second occlusion device 16 may be provided. The secondocclusion device 16 may be positioned at a landmark 40 b such as a GEjunction or GEJ of the stomach 40 and wrapped around, for example, theesophagus to occlude fluid or gas from passing beyond the landmark 40 bin direction B. The second occlusion device 15 may be a clamp, penroseor elastomeric band that may be positioned at the landmark 40 b andwrapped around the esophagus to prevent fluid or gas from passingtherebeyond.

According to an additional or alternative example (not shown in FIGS.3-4, but shown, for example, in FIG. 12), the second occlusion device 16may be integrated into the first medical device 10 and adjusted to bepositioned at the landmark 40 b as described herein.

As shown, a second medical device 20 may be provided. The second medicaldevice 20 may be positioned on an exterior of the stomach 40. The secondmedical device may be a clamp, a single cartridge sleeve gastrecomtystapler, and/or the like. The second medical device 20 may span a lengthof a potential staple line or resection line of the stomach 40undergoing the sleeve gastrectomy such that it may be configured todemonstrate or create a path such as a resection line or staple linealong the stomach 40 at which the sleeve gastrectomy may be performed.In one example, the second medical device 20 may be positioned on theexterior of the stomach relative to the first medical device (e.g.,adjacent to, near, in proximity to, and/or the like). In such anexample, the first medical device 10 may be used as a reference toposition the second medical device 20. The second medical device 20 mayslide or move along the exterior of the stomach prior to stapling basedon a sleeve volume that may be measured for a potential resultantsleeve. The second medical device 20 may also not enable fluid or gas topass beyond laterally in direction C and in conjunction with the firstmedical occlusion device 12 and second occlusion device 16 may define apotential resultant sleeve that may fluid and gas may be trapped withinto measure volume as described herein.

According to examples, the second medical device 20 may be a clamp orstapler that may be adjusted or at least partially closed or fullyclosed by adjusting resistance of a cable thereof (not shown) in a loopcable assembly included therein (not shown). In such an example,resistance may be provided by springs (not shown) that resist the cablebeing pulled. The spring constant may be different in the proximal andthe distal end of the second medical device 20 and, thus, one end may bepulled down before the other such that the stomach may be manipulated atdifferent points or part. Additionally, in examples, the second medicaldevice 20 may have different traction surfaces along the length thereofsuch that different points or parts of the stomach may be manipulatedwithout allowing movement of other points or parts (e.g., differentparts of the stomach may be clamped while others may not be). The secondmedical device 20 may further be wider along portions thereof (e.g., mayhave a non-uniform width). For example, the second medical device 20 maybe wider along a portion that may be positioned near a landmark such asan IA of the stomach 40.

As shown, in performing the sleeve gastrectomy (e.g., a method orprocedure thereof), the first medical device 10 may be inserted into thestomach 40 and adjusted proximally and distally such that firstocclusion device 14 may be positioned at the landmark 40 a (e.g., nearor around the pylorus). As shown, the second occlusion device 16 may bepositioned at the landmark 40 b. The first occlusion device 14 may beinflated to occlude fluid or gas from passing in direction A beyond thelandmark 40 a. For example, the first medical device 10 may bepositioned along the lesser curve of the stomach 40 with the firstocclusion device 12 beyond or past the landmark 40 a (e.g., thepylorus). The first occlusion device 12 may be inflated and withdrawn towithstand pressure (for example, 70 cm H20) and to enable gas to betrapped in a potential resultant sleeve (i.e., not allow gas to passbeyond the landmark 40 a or the occlusion point produced thereby). Thesecond occlusion device 16 may be wrapped or secured around the landmark40 b as shown in an example to occlude fluid or gas from passing indirection B beyond landmark 40 b.

The second medical device 20 may be positioned on the exterior of thestomach 40 (e.g., as shown) at a location a surgeon may desire or maybelieve produces a resultant sleeve with a desired shape, size, and/orvolume. According to an example (e.g., after positioning the secondmedical device 20 at the desired location), the second medical device 20may be at least partially closed thereby forming a potential resectionline and a potential resultant sleeve formed thereby. As describedherein, the first occlusion device 14 of the first medical device 10,second occlusion device 16, and second medical device 20 may define apotential resultant sleeve and may prevent gas or fluid from escapingsuch a sleeve when determining a volume thereof.

In an example (e.g., upon occluding at the landmarks 40 a, 40 b andpositioning the second medical device 20), an amount (e.g., apredetermined or predefined amount) of fluid such as water, salinesolution, and/or the like or gas may be inserted into the first medicaldevice 10 at a proximal end thereof (e.g., via the port not shown) andmay pass therethrough out of the apertures or openings 12 and into theportion of the stomach 40 defined by the area created by the first andsecond occlusion devices 14, 16 at the landmarks 40 a, 40 b respectivelyand and the path along the second medical device 20. In an example, theamount of fluid or gas may be between from about 20 ml to about 200 ml.

Pressure may be measured (e.g., using a pressure measurement device notshown) and a volume of the potential resultant sleeve defined by thelandmarks 40 a, 40 b and second medical device may be calculated basedon the amount of fluid or gas used and the pressure measured therefrom.

According to an example, the volume may be used to determine whether thepotential resultant sleeve may be suitable for resection and/or mayprovide a desired resected or permanent resultant sleeve size, shape,and/or the like. For example, if based on the measurement and/orcalculation, the volume may be too low to provide a resected resultantsleeve desired by a surgeon, the second medical device 20 may be movedlaterally along the exterior surface away from the landmarks 40 a, 40 band/or the IA such that the potential resultant sleeve may becomelarger. Likewise, in an example, if based on the measurement and/orcalculated, the volume may be too high to provide a resected resultantsleeve desired by a surgeon, the second medical device 20 may be movedmedially along the exterior of the stomach toward the landmarks 40 a, 40b and/or the IA of the stomach 40 such that the potential resultantsleeve may become smaller. The pressure may be re-measured in responseto moving the second medical device 20 to determine whether subsequentmedial or lateral movements as described herein may be needed thereto toachieve a desired resected or permanent resultant sleeve.

In an example (e.g., upon reaching a suitable volume or desired volume),the sleeve gastrectomy (e.g., resection of part of the stomach 40) maybe performed along the path produced by the second medical device. Forexample, the surgeon may fully engage the second medical device 20 andmay resect the stomach along the path to produce the resected resultantsleeve or permanent resultant upon reaching a suitable volume that mayproduce a resected or permanent resultant sleeve of the stomach. Forexample, a resection or staple line may be created (e.g., using asurgical stapler) along the path (e.g., staple line or resection line)thereby producing the resected or permanent resultant sleeve. In one ormore examples herein, the resultant sleeve of the stomach that may becreated by the path (e.g., the resection or staple line) may include adiameter of from about 1 cm to about 3 cm near the first landmark (e.g.,the IA), from about 2 cm to about 6 cm near a second landmark (e.g., apylorus) of the stomach, and from about 0 cm to about 2 cm near a thirdlandmark (e.g., a gastroesophageal junction (GEJ) or GE junction) of thestomach.

In an example, the second medical device 20 may be positioned before thefirst medical device. That is, the surgeon may position the secondmedical device on the exterior of the stomach to create a lateralboundary of a potential resultant sleeve as described herein and my theninsert the first medical device 10 and create the additional boundariesat the landmarks 40 a, 40 b respectively as described herein.

FIGS. 5-18 depict additional or alternative devices that may be used tomeasure sleeve volume in one or more examples herein including themethod or procedure described with reference to FIGS. 3-4. As shown inFIGS. 5-8, in an example, rather than occluding the gastric outlet andthe gastric inlet (e.g., at the landmarks 40 a, 40 b as describedabove), the first medical device 10 may include a compliant balloon 30that may be used to fill the space of the proposed or potentialresultant sleeve (e.g., as shown in FIG. 7). The second medical device20 may occlude the lateral border as described herein and the balloonmay be filled until a desired pressure may reached at which point volumemay be measured or assessed. In an additional or alternative example, aheight of the compliant balloon may be adjusted with a sheath 32 asshown in FIGS. 7-8 so the balloon may be positioned distal to thelandmark 40 b or the esophagus and proximal to the landmark 40 a or thepylorus as described herein. A pressure bag or elevation of an opensyringe to a given height above the cricoid (e.g., 70 cm of water) maybe used to assess the volume by the displacement recorded from thecontainer into the proposed sleeve. This may be performed before orafter stapling the stomach to assess volume of the sleeve pouch.According to an example, if done prior to stapling, the surgeon may havethe ability to adjust the position of the stapler to achieve an optimalsize and shape under pressure.

Further, in an example, as shown in FIGS. 9-11, the first medical device10 may include a compliant balloon 30 that may be combined with atwo-diameter tube, a three-diameter tube, a balloon tipped orogastriccalibration tube, and/or the like. In this example, a desired positionfrom the incisura angularis (IA) may be obtained and volume may bemeasured in the same orogastric calibration tube 34 as shown in FIG. 9.An additional cylindrical balloon 36 and/or 38 may be positioned alongthe upper portion and lower portion of the orogastric tube with a widerballoon 39 at the incisura angularis and a compliant balloon 30therearound to measure volume of the sleeve as shown in FIGS. 10-11. Inan example, the medical device 20 may include a single cartridge sleevegastrectomy stapler that may be positioned alongside points of thestomach (e.g., points 1, 2, and 3 as described in U.S. patentapplication Ser. No. 14/846,764 or PCT/US15/48740, the contents of whichare incorporated herein in their entirety by reference). Additionally,the balloon and tubes may enable different fill times to measure volume.For example, the balloon adjacent the incisura angularis (e.g., 40 c)may fill first, the first and/or second cylindrical balloons may fillsecond and third, and the large compliant balloon may fill last orfourth. The timing of the balloon filling may accomplished by the sizeof the openings or apertures (e.g., such as 12) to the lumen of theorogastric tube. The largest opening will fill first as it has the leastresistance to flow. The balloon adjacent the incisura angularis may havethe largest opening to the tube lumen and may fill first. Thecylindrical balloons may have multiple openings that may have moreresistance than the incisura angularis but less resistance than thevolume balloon and may fill second and/or third. The volume balloon,even though more compliant, may fill after the incisura angularis andcylindrical balloons may be filled to capacity and are under pressure.Thus, the surgeon may be able to position the stapler at safe distancesfrom key landmarks then measure volume. The volume may be measured bydisplacement or pressure as described herein.

As shown in FIG. 12-13, the second occlusion device 16 may be integratedor included in the first medical device 10. For example, as shown, thefirst medical device 10 may include a first tube with the firstocclusion device 16 and a second tube that may be placed over the firsttube that may include the second occlusion device 16 such that the firstand second tubes may slides proximally and distally with respect to eachother to position the first occlusion device 14 at the first landmark 40a and the second occlusion device 16 at the landmark 40 b as describedherein.

In an example, as shown in FIG. 14, the first medical device 10 mayinclude a set of at balloons 50, 52, and/or 54 that may be compliantsuch that they may be inflated to measure volume and also may not exceeda shape of a resultant sleeve desired by the surgeon. As shown, thefirst medical device 10 that may include the balloons may be used withthe second medical device 20 as described. Alternatively oradditionally, in an example, the first medical device may include anon-compliant backbone along the edge adjacent to the second medicaldevice 20 such that the second medical device 20 may not be used.

According to examples, the first medical device 10 described herein mayalso include one or more portions 60 that may be wider at a landmark 40c such as the IA of the stomach 40 as shown in FIGS. 15-18. For example,the first medical device 10 may include a constant diameter along aportion thereof and may have a wider diameter (e.g., after inflation,actuation, and/or the like) along the lesser curve or the landmark 40 c(e.g., the IA).

Although examples herein may be described with respect to measuringvolume, the examples may also be used with one or more of the examplesdescribed in U.S. patent application Ser. No. 14/846,764 orPCT/US15/48740, the contents of which are incorporated herein in theirentirety by reference.

While several devices and components thereof have been discussed indetail above, it should be understood that the components, features,configurations, and methods of using the devices discussed are notlimited to the contexts provided above. In particular, components,features, configurations, and methods of use described in the context ofone of the devices may be incorporated into any of the other devices.Furthermore, not limited to the further description provided below,additional and alternative suitable components, features,configurations, and methods of using the devices, as well as variousways in which the teachings herein may be combined and interchanged,will be apparent to those of ordinary skill in the art in view of theteachings herein.

Versions of the devices described above may be actuated mechanically orelectromechanically (e.g., using one or more electrical motors,solenoids, etc.). However, other actuation modes may be suitable as wellincluding but not limited to pneumatic and/or hydraulic actuation, etc.Various suitable ways in which such alternative forms of actuation maybe provided in a device as described above will be apparent to those ofordinary skill in the art in view of the teachings herein.

Versions of the devices described above may have various types ofconstruction. By way of example only, any of the devices describedherein, or components thereof, may be constructed from a variety ofmetal and/or plastic materials.

Having shown and described various versions in the present disclosure,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, versions, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

What is claimed is:
 1. A method of performing a sleeve gastrectomy on astomach of a patient, comprising: positioning a first medical device inthe interior of the stomach, the first medical device including a firstocclusion device at a distal end thereof, the first medical device beingpositioned by inserting the first medical device into the mouth of thepatient to access the interior of the stomach and positioning the firstocclusion device at a landmark of the stomach, the first occlusiondevice defining a distal boundary of a potential resultant sleeve;positioning a second occlusion device of the first medical device atanother landmark of the stomach, the second occlusion device defining aproximal boundary of the potential resultant sleeve; and positioning asecond medical device on the exterior of the stomach relative to thefirst medical device, the second medical device being configured todefine a lateral boundary of the potential resultant sleeve and a pathalong which the sleeve gastrectomy may be performed; and determining avolume of the potential resultant sleeve, wherein determining the volumeof the potential resultant sleeve further comprises one or more of thefollowing: filling the potential resultant sleeve to a predeterminedpressure with fluid or gas, the fluid or gas configured to be trapped inthe potential resultant sleeve by the distal, proximal, and lateralboundaries created by the first occlusion device, the second occlusiondevice, and the second medical device; and measuring the volume of thepotential resultant sleeve at the predetermined pressure.
 2. The methodof claim 1, further comprising performing the sleeve gastrectomy alongthe path created by the second medical device, if based on thedetermination, the volume of the potential resultant sleeve may be adesired or suitable volume for a resected resultant sleeve.
 3. Themethod of claim 1, further comprising adjusting the second medicaldevice laterally if, based on the determination, the volume of thepotential resultant sleeve may be too low or too high, andre-determining the volume of the potential resultant sleeve.
 4. Themethod of claim 1, wherein the second medical device may be a clamp. 5.The method of claim 1, wherein the second medical device may be astapler.
 6. The method of claim 1, wherein the first medical device mayinclude a medical tube.
 7. The method of claim 1, wherein the firstocclusion device may be a balloon.
 8. A medical device for a sleevegastrectomy comprising: a first medical device comprising at least afirst occlusion device at a distal end thereof, the first medical devicebeing configured to be inserted into an interior of a stomach and thefirst occlusion device being configured to be positioned at a landmarkthereof to occlude a portion of the stomach and define a distal boundaryof a potential resultant sleeve; a second occlusion device, the secondocclusion device being configured to be inserted into the interior ofthe stomach or positioned on an exterior of the stomach, the secondocclusion device being configured to be positioned at another landmarkof the stomach to occlude another portion of the stomach and define aproximal boundary of the potential resultant sleeve; and a secondmedical device being configured to be positioned on the exterior of thestomach relative to the first medical device, the second medical devicebeing configured to define a lateral boundary and a path along which thesleeve gastrectomy may be performed, the lateral boundary along with theproximal and distal boundaries and occlusion thereof being configured toenable a measurement of a volume of the potential resultant sleeve,wherein the volume of the potential resultant sleeve may be configuredto be determined by one or more of the following: filling the potentialresultant sleeve to a predetermined pressure with fluid or gas via thefirst medical device, the fluid or gas being configured to be trappedinto the potential resultant sleeve by the distal, proximal, and lateralboundaries created by the first occlusion device, the second occlusiondevice, and the second medical device respectively; and measuring thevolume of the potential resultant sleeve at the predetermined pressure.9. The device of claim 8, wherein the second medical device is a clamp.10. The device of claim 8, wherein the second medical device is astapler.
 11. The device of claim 8, wherein the first occlusion deviceis a balloon.